CHEMILUMINESCENT SYSTEM ALLERGAN SPECIFIC IGE

CHEMILUMINESCENT SYSTEM ALLERGAN SPECIFIC IGE is an FDA 510(k)-cleared medical device (K914850) manufactured by Mast Immunosystems. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 8, 1991. Regulation: 8.